Despite the advent of newer biologic therapies such as infliximab for Crohn's disease, a form of autoimmune inflammatory bowel disease, a proportion of patients are refractory to such therapy and require surgery. The hypothesis is that mesenchymal stromal cell therapy using third party human cultured cells will be safe and effective
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
MSC 2X10E6/kg recipient weight are infused over 15 minutes intravenously weekly for 4 weeks
Department of Gastroenterology and Hepatology, Royal Perth Hospital
Perth, Western Australia, Australia
Clinical response to MSC: Reduction of Crohn's disease Activity score by 100 points or more at six weeks post start of therapy
Colonoscopy and biopsy as well as clinical parameters used for the Crohn's disease acivity (www.ibdaustralia.org/cdai/) will be undertaken at screening pre-therapy and at 6 weeks after start of therapy.
Time frame: Six weeks
Incidence of infusional toxicity
Subjects will receive mesenchymal stromal cell therapy, 2X10E6/kg weekly by IV infusion for 4 weeks and will be assessed for 4 hours post infusion
Time frame: Six weeks
Induction of remission
Crohn's disease activity index assessed as below 150
Time frame: Six weeks
Improved quality of life
Increase in IBDQ and SF-36 scores measured at six weeks
Time frame: Six weeks
Endoscopic improvement.
Crohn's disease endoscopic improvement score will be measured at repeat endoscopy six weeks after start of treatment
Time frame: Six weeks
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